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Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00128908
Recruitment Status : Terminated (Did not recruit)
First Posted : August 10, 2005
Last Update Posted : September 15, 2009
Sponsor:
Collaborator:
Dutch AIDS Fund
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Tracking Information
First Submitted Date  ICMJE August 8, 2005
First Posted Date  ICMJE August 10, 2005
Last Update Posted Date September 15, 2009
Study Start Date  ICMJE September 2005
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
Changes in plasma HIV-1 RNA load [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2005)
Changes in plasma HIV-1 RNA load.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
  • Changes in the genotype of the dominant quasispecies [ Time Frame: 12 weeks ]
  • Replicative fitness of the dominant quasispecies [ Time Frame: 12 weeks ]
  • Changes in CD4+ and CD8+ cell counts [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2005)
  • - Changes in the genotype of the dominant quasispecies
  • - Replicative fitness of the dominant quasispecies
  • - Changes in CD4+ and CD8+ cell counts
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients
Official Title  ICMJE Sequential HAART in Treatment Resistant HIV-1 Infected Patients
Brief Summary This is an open label, crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy.
Detailed Description

Mathematical modeling has suggested that cyclic use of antiretroviral therapy can be an effective strategy in lowering viral load in HIV-1 infected patients when regular triple drug combinations have lost efficacy due to the emergence of HIV resistance mutations.

This is an open label, crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy.

The objectives are to study the feasibility, safety and efficacy of sequential combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral agents and who currently have no adequate treatment options available.

This is an open-label, crossover, pilot study. Patients that fail their current regimen, and who currently have no adequate treatment options left, will be randomized to start either an alternating triple combination, or to start a continuous quadruple regimen of drugs. After 6 weeks, patients will crossover from either strategy to the other strategy for another 6 weeks. Each period is preceded by an interruption of all antiretroviral therapy for 4 weeks. In the study period when regimens are alternated, two combinations of three drugs with the least possible cross-resistance will alternate every week.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART)
  • Drug: Rapidly Cycled HAART
Study Arms  ICMJE
  • Active Comparator: Continuous triple-class therapy
    Patients will be treated with a regimen containing antiretroviral agents from 3 different classes
    Intervention: Drug: Standard Continuous Highly Active Antiretroviral Therapy (HAART)
  • Experimental: Alternating therapy
    Patients will be assigned to weekly alternating dual-class regimen
    Intervention: Drug: Rapidly Cycled HAART
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 14, 2009)
3
Original Enrollment  ICMJE
 (submitted: August 8, 2005)
12
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV-1 infected patients
  • At least 18 years of age
  • Males or non-pregnant, non-lactating females
  • Documented virological treatment failure on at least 3 classes of antiretroviral drugs
  • No adequate antiretroviral therapy possible with currently available antiretroviral agents
  • Virological treatment failure is defined as plasma HIV-1 RNA levels > 5000 while taking at least three different antiretroviral drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00128908
Other Study ID Numbers  ICMJE 05IAT0061
2004040 - Dutch AIDS Fund
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. J. Prins, Academic Medical Center, Amsterdam
Study Sponsor  ICMJE Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators  ICMJE Dutch AIDS Fund
Investigators  ICMJE
Study Chair: Joep MA Lange, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Director: Ferdinand Wit, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP